Singapore HSA Updates Guidelines on Software Medical Devices (GL-04)

The revised guideline includes several key changes:

• Document title has been updated to include machine learning-enabled medical devices.
• New and revised definitions have been added for “Machine Learning”, “AIMD”, “Cybersecurity”, “compensating controls”, and “SaMD” for international alignment.
• The term “Standalone software” has been replaced with “SaMD” for international alignment.
• Provide clarity on cybersecurity and machine learning-enabled medical devices (MLMD).
• Provide clarity on medical device operating systems.

 

The finalised guideline can be accessed here and will be effective 31 Dec 2025:

https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gl-04-r4-regulatory-guidelines-for-software-medical-devices—a-life-cycle-approach-(2025-dec)-pub.pdf?sfvrsn=857a2001_1